Griffin Hospital News Releases

Insulin Pen Notification

9-19-2014 - Information Update:

Clarification and Correction To 9-13-14 New Haven Register News Story

Griffin Hospital would like to clarify and correct some of the information contained in the “Ansonia man dealing with hepatitis C following Griffin Hospital mishap” story that ran in the Saturday, September 13 edition of the New Haven Register:

Griffin Hospital continues to communicate individually with the more than 1,300 individuals who took advantage of its offer to test patients for possible exposure to Hepatitis B, C, and HIV as part of the hospital’s response to the insulin pen misuse identified in May. This includes the reporting of negative test results, the possible need for follow up testing based on the date of a patient’s last admission, and any positive tests for the three diseases.

As the hospital stated in its May 16 press conference, any patient testing positive for one of the three blood borne diseases who had not been known to be positive prior to their potential exposure at Griffin would be provided with information about treatment options and offered the appropriate treatment (as determined by the patient and their physician) at the hospital’s expense. Griffin Hospital has also made a care coordinator available to help patients navigate the decision making and treatment process.

While there is no way to determine definitively that a new positive test finding is the result of exposure from insulin pen misuse, the hospital is committed to providing the individualized care needed in the best interest of its patients. Moreover, despite the high prevalence of hepatitis C in the general population and the numerous risk factors for acquiring the disease, the hospital has no interest in speculating on how any newly diagnosed patient may have contracted Hepatitis C. Rather, the hospital is focused on working with patients to determine the best course of treatment for their individual situation.

In the case of hepatitis C, as the article notes, the best course for most patients is to wait for the availability of a new generation of drug therapy, expected to be introduced in October, before beginning treatment. Studies have shown the next generation interferon-free therapies to be 97-99% curative, shorter in duration, and better tolerated by patients than the currently available drugs. What’s more, because hepatitis C progresses slowly, the prudent action for most patients is to wait for the new drug regimen to be available to start treatment, with the benefits of doing so outweighing the risk of waiting, if there are any. This decision, however, remains one that the patient and his or her physician must make, taking into consideration their individual circumstances and their assessment of the information provided.

The hospital regrets that the patient featured in the article is facing a hepatitis C diagnosis, and therefore remains committed to providing optimal care and treatment at no expense to him or his family.

The article also attributes the following to statement to Dr. Harold Schwartz: “Symptoms of hepatitis C include flu-like symptoms, bone marrow suppression production (anemia), and it also has psychiatric side effects including depression.” These were actually described by Dr. Schwartz as some of the possible side effects of various hepatitis treatment regimens, not symptoms of the disease itself.

In fact, hepatitis C is a disease that remains “silent” in many patients until it reaches an advanced state, which is why so many people are not diagnosed until the disease progresses into its late stages. This is also why the national Centers for Disease Control and Prevention (CDC) has recommended hepatitis C testing for all members of the baby boom generation, because of the disproportionate prevalence of the disease (greater than 3%) in that portion of the adult population. In recognition of this fact, the Connecticut General Assembly enacted PA14-203, An Act Concerning Hepatitis C Testing, which seeks to increase the number of patients who are tested for hepatitis C, consistent with the announced goal of the CDC. Effective October 1, 2014, the law will require licensed primary care physicians, advanced practice registered nurses, and physician assistants to offer to proved or order a hepatitis C screening or diagnostic test for patients born between 1945 and 1965 when providing services to those patients.

Finally, Dr. Schwartz is quoted as saying “No one is treating it like a crisis.” His statement appears to be taken out of context, as he is referring to the fact that the insulin pen misuse is not a public health crisis, but rather an isolated situation affecting a limited amount of patients. This should not be interpreted as a lack of urgency or seriousness with which the hospital is approaching the situation, as the rest of the quote attributed to Dr. Schwartz more accurately describes.

6-10-14 Information Update:

Griffin Hospital Insulin Pen Safety Event FAQs – May 16, 2014

* INFORMACIÓN RELACIONADA A ESTA NOTIFICACIÓN

What are insulin pens?

Insulin pens are injector devices that contain a multi-dose vial of insulin, also referred to as an insulin cartridge. Thousands of hospitals across the nation utilize insulin pens. At Griffin Hospital, these pens were used for hospitalized patients only. The pens are intended for single person use only and are designed to allow for the delivery of multiple doses. The retractable, single-use needle that attaches to the insulin pen is disposable, allowing reuse of the pen-like injector with a new sterile safety needle for each use.

Were needles reused at Griffin Hospital and how could the insulin pen transmit a virus?

No. To the extent that improper use of pens did occur, the hospital is certain that pen needles were not reused because Griffin Hospital has always used safety needles that prevent a needle from being used for more than a single injection. However, even when using a new needle, the possibility exists that a pen’s insulin cartridge can be contaminated through the backflow of blood or skin cells from one patient, and thus potentially transmit an infection if used on another.

What is the risk of exposure?

The risk of disease transmission is considered extremely small. At this time there is no evidence that disease transmission has occurred to any patient at Griffin Hospital resulting from improper use of insulin pens, and the hospital has not identified any patients that in fact received an insulin injection from an insulin pen used on another patient. Nevertheless, there is a remote possibility that patients could have been exposed to certain blood-borne infections, so Griffin Hospital is strongly encouraging approximately 3,100 patients for whom an insulin pen was ordered during their hospitalization at Griffin Hospital on or after September 1, 2008 and before May 7, 2014 to be tested for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) as a precautionary measure. The hospital is sending these patients letters by first class and registered mail encouraging them to seek testing within 30 days of receipt of the letter.

How do patients get tested at Griffin?

Patients receiving the letters are encouraged to call special phone lines, staffed by Griffin Hospital nurses and pharmacists, to coordinate an appointment for confidential testing or to speak with a medical professional if they have questions of any kind.

Is there a cost to get tested?

There will be no charge for any screenings, testing, or counseling provided by Griffin Hospital related to this matter, and testing results will be provided within seven days to patients and their primary care physician. If patients prefer to obtain their testing through another healthcare provider, they may do so, and are instructed to call the hospital for the appropriate testing information.

What is the test?

The approximately 3,100 patients for whom an insulin pen was ordered during their hospitalization at Griffin Hospital on or after September 1, 2008 and before May 7, 2014 are being offered a simple blood screen will test for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). The testing protocol will vary depending on the date of patients’ most recent hospitalization. If the patients’ physician ordered an insulin pen for them during a recent hospitalization, the hospital is recommending that they have initial testing and follow-up testing. If the patients were hospitalized more than six months ago, the hospital is recommending that they have a single panel of tests.

Why is Griffin Hospital doing this outreach?

The hospital is trying to be as proactive and thorough as possible to ensure the safety and well-being of its patients. Griffin Hospital believes it is our responsibility to contact these approximately 3,100 patients in the event that inappropriate use of an insulin pen may have occurred, no matter how unlikely the potential for disease transmission.

From Our Griffin Family to Yours

At this time there is no evidence that disease transmission has occurred to any patient at Griffin Hospital resulting from improper use of insulin pens and we have not identified any patients that in fact received an insulin injection from an insulin pen used on another patient. Regardless, Griffin Hospital is notifying inpatients for whom an insulin pen was ordered during their hospitalization on or after September 1, 2008 and before May 7, 2014 (the date when Griffin Hospital discontinued use of the insulin pens)

At Griffin Hospital the quality and safety of the care we provide is our primary concern. We value our relationship with our patients and the trust they place in us, and sincerely apologize for any concern this matter may cause you.

Derby, CT May 16, 2014 – Griffin Hospital is announcing today that it has identified the possibility that insulin pens ordered for patients hospitalized between September 1, 2008 and May 7, 2014 may have been misused, exposing those patients to possible disease transmission. Insulin pens are injector devices that contain a multi-dose vial of insulin, also referred to as an insulin cartridge. Thousands of hospitals across the nation utilize insulin pens. The pens are intended for single person use only and are designed to allow for the delivery of multiple doses. The single-use, retractable needle that attaches to the insulin pen is removable, allowing reuse of the pen-like injector with a new sterile safety needle for each use.

At Griffin Hospital, insulin pens were used for hospitalized patients only. To the extent that improper use of pens did occur, the hospital is certain that pen needles were not reused because Griffin Hospital has always used safety needles that prevent a needle from being used for more than a single injection. However, even when using a new needle, the possibility exists that a pen’s insulin cartridge can be contaminated through the backflow of blood or skin cells from one patient, and thus could potentially transmit an infection if used on another patient. The risk of disease transmission is considered extremely small. At this point, the hospital’s review has not identified any specific patient who has received an insulin injection from another patient’s insulin pen, and there is no evidence of any transmission of blood-borne infection due to insulin pen misuse. However, because Griffin Hospital identified improper use of the pens, the hospital recommends that patients hospitalized at Griffin between September 1, 2008 and May 7, 2014 for whom an insulin pen was ordered, be tested for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) as a precautionary measure. The hospital is recommending that these patients be tested within the next 30 days.

Griffin Hospital has established dedicated phone lines that will be staffed from 7 a.m. to 10 p.m., seven days a week. The hot line numbers are 203.732.1411 and 203.732.1340. Patients that call these phone lines can coordinate an appointment for confidential testing or speak with a nurse or pharmacist to answer any questions. There will be no charge for any screenings, testing, or counseling provided by Griffin Hospital related to this matter, and testing results will be provided within seven days to patients and their primary care physicians.

At this time there is no evidence that disease transmission has occurred to any patient at Griffin Hospital resulting from improper use of insulin pens, and the hospital has not identified any patients that in fact received an insulin injection from an insulin pen used on another patient. Regardless, Griffin Hospital is notifying patients, by first-class and certified mail, for whom an insulin pen was ordered during their hospitalization on or after September 1, 2008 and before May 7, 2014 and offering free and confidential testing for hepatitis B, hepatitis C and HIV. The hospital is strongly encouraging these patients to be tested within 30 days of receipt of their letters.

For more information, visit griffinhealth.org/insulinpennotification.

For more information:Ken RobertsDirector, Communications and Public AffairsGriffin HospitalTel. 203-732-7432kroberts@griffinhealth.org